Danaher Corporation Quality Systems Specialist I in Lodi, California
Responsible for general support and maintenance of the Quality System within the requirements of FDA's Quality System Regulation (QSR) and ISO 13485 (ISO). Batch record review and product release within a GMP manufacturing environment at our Lodi Facility
ESSENTIAL JOB RESPONSIBILITIES:
Review records and documents for completeness and compliance with QSR and ISO requirements.
Create Certificate of Conformances for each lot released.
Review the QC measurement data and upload the data and Certificate of Conformance into an on-line database for each lot.
Create and apply approval labels for release products.
Coordinate with the Shipping Department the shipping of release parts to the production facilities.
Perform material movement and release transactions in the company’s ERP system.
Create and Maintain inventory of retains samples that are stored offsite.
Assist with corrective action activities in the resolution of issues.
Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports.
Participate in interdepartmental initiatives for continuous improvement.
Generate standard operating procedures to define and improve quality system functions.
Support QS Manager to implement and monitor Manufacturing and Quality Systems procedure.
Review records and documents, for completeness and compliance with QSR and ISO requirements.
Support the eDMS electronic documentation process as needed.
TRAINING RESPONSIBILITIES: (REQUIRED)
- Complete all assigned and required training satisfactorily and on time
Education and Experience (in years):
High school diploma with 0-1 years of work experience in a manufacturing environment.
Must be familiar with ISO standards and applicable regulatory requirements (CE/FDA/QSR)
Knowledge and skills:
Excellent verbal and written communication skills in group or one-on-one settings.
Computer skills, e.g., word, excel, access, Microsoft project, electronic documentation systems.
Ability to interface well with people of varied backgrounds, and to guide groups toward effective dynamics.
Understanding of general mathematical principles and calculations, at college entry level.
Experience in compiling data to support metrics analyzing current process.
Understanding root cause analysis, failure analysis and general troubleshooting principles, and the ability to transfer those skills to others, either individually or in a group setting.
Detailed and quality oriented.
Strong organizational skills.
Ability to work in an office environment
Maintain flexibility in work schedule as interface with personnel on 2nd and weekends shifts are required.
Frequent walking between locations
Experience in DNA diagnostics or other medical devices
Associate degree a plus but not required.
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
As part of the Danaher family of companies, our work at Cepheid is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, this relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
Operating Company: Cepheid